Customizable ear insert

ABSTRACT

The present invention provides a customizable ear insert for fitting within a user&#39;s outer ear or ear canal or both and methods therefor. In accordance with an aspect of the present invention, there is provided a customizable ear insert having: a body formed of photocurable polymer, the body having a first shape configured for insertion into the outer ear canal of a user; a light source, the light source positioned adjacent the body, and wherein the body can be cured into a second shape by application of light generated by the light source, the second shape snugly conforming to the interior surface of the user&#39;s outer ear or ear canal or both.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 16/263,478, filed Jan. 31, 2019, which is acontinuation application of U.S. patent application Ser. No. 15/109,104,filed May 27, 2015, which is a National Stage Entry of PCT/CA2015/050479filed May 27, 2015 and claims benefit of priority from U.S. ProvisionalPatent Application Ser. No. 62/005,276, filed May 30, 2014, the entirecontents of which are incorporated herein by reference.

FIELD

The present invention pertains to the field of wearable technology andin particular to custom moldable ear inserts for use in a wide varietyof applications.

BACKGROUND

Custom-fit earpieces allow for a better fit of the earpiece in one'sear. A custom earpiece's superior noise-suppression can diminish all orat least significant levels of background noise and thereby canincreases the prominence of the sounds that the user is trying to listento and protect the user from potentially dangerous environmental sounds.If a custom fit earpiece is used as an earphone, with less environmentalnoise overpowering the subtle/quiet details in the music, the user isable to listen at lower volume levels which can result in a safer userexperience. More specifically, custom fit earpieces can offer less riskof injury in ear drums as the volume levels can remain lower, and theprovided superior fit and increased comfort level can allow for a userto listen for a longer period of time without incurring injury.

The two primary problems associated with custom-fit earpieces areproduction cost, and the fitting process. For example, the cost for anaverage pair of custom earphones is currently beyond the earphone budgetset aside by most consumers. In addition, custom earpieces generallyrequire the consumer to visit an audiologist to make impressions of theear canals which incurs additional cost and time.

Therefore there is a need for a customizable ear insert providing highaudial performance and provided at a lower economic price point thancurrent industry standards.

This background information is provided to reveal information believedby the applicant to be of possible relevance to the present invention.No admission is necessarily intended, nor should be construed, that anyof the preceding information constitutes prior art against the presentinvention.

BRIEF SUMMARY

It is contemplated that the present invention can provide a customizableear insert In at least one embodiment, a customizable ear insert forinsertion into the outer ear or ear canal or both of a user is providedhaving a body formed of photocurable polymer, the body having a firstshape configured for insertion into the outer ear or ear canal or both,a light source, the light source positioned adjacent the body, andwherein the body can be cured into a second shape by application oflight generated by the light source, the second shape snugly conformingto the interior surface of the outer ear or ear canal or both.

In another embodiment, the present invention provides a method ofcalibrating a photocurable customizable ear insert for fit within theouter ear or ear canal or both of a user, the method having the steps ofreceiving information from one or more feedback modules via acommunication means, comparing the information to a database withpredetermined calibration values, outputting instructions to thecustomizable ear insert components for implementation whereinimplementation comprises at least curing the photocurable customizableear insert into a second shape by application of light generated by alight source, the second shape snugly conforming to the interior surfaceof the outer ear or ear canal or both.

BRIEF DESCRIPTION OF THE FIGURES

Embodiments of the present invention will be better understood inconnection with the following Figures, in which:

FIG. 1 illustrates a side cutaway view of one embodiment of acustomizable ear piece in accordance with the present invention;

FIG. 2 illustrates a side cutaway view of another embodiment of acustomizable ear piece in accordance with the present invention; and

FIG. 3 illustrates perspective views of different embodiments of acustomizable ear piece in accordance with the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS Definitions

As used herein, the term “device” beyond its ordinary meaning, can bedefined as any apparatus capable of network access. The device may bewired or wireless. In at least one embodiment, the device may include apersonal computer, tablet, mobile device, mobile phone, television,music player, personal organizer, or any similar electronic networkenabled device. In at least one embodiment, the device may be wearabletechnology with network enablement including, but not limited to,jewelry, watches, glasses, hats, clothing, shoes, socks and similarwearable technology reasonably contemplated by one skilled in the art.In at least one embodiment, the device may be a corporately ownedpersonal computer, tablet, mobile device, mobile phone, personalorganizer, or any similar electronic network enabled device.

As used herein, the term “App” can be defined as an Applicationimplemented on a device. The Application may be downloaded and locallyinstalled on the device with minimal retrieval of extraneous data froman external network. In at least one embodiment, the Application is a“thin client” on the device and retrieves substantial amounts ofinformation from an external network. In at least one embodiment, theApplication is accessed through a network client (e.g., web browser,third party aggregator application). In at least one embodiment, theimplementation of the Application may include a hybrid of conventionalparadigms such as those described above.

As used herein, the term “communication means”, beyond its ordinarymeaning, can be defined as any means between the ear piece and thedevice or any other third party receiving mechanism allowing for signalreception and/or data packet reception. In at least one embodiment, thecommunication means may be digital and include any necessary elements ofhardware, including but not limited to communications ports, wirelesstransmitter/receivers, wires or fiber optics; and software, includingbut not limited to telephony, e-mail, facsimile, Bluetooth®, NFC,TCP/IP, FTP, XML, and IRC, that allow a device to exchange data packetswith another device. In at least one embodiment, the communication meansinclude USB connectivity, Apple® Lightning cable, Fire wire, Ethernet,auxiliary cable, and similar connectivity standard readily known by theskilled person.

As used herein, the term “about” refers to a +/−10% variation from thenominal value. It is to be understood that such a variation is alwaysincluded in a given value provided herein, whether or not it isspecifically referred to.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs.

Customizable Ear Insert Overview

In at least one embodiment, the present invention provides acustomizable ear insert which may be utilized for any number ofapplications for which custom ear inserts provide utility such as earplugs, hearing aids, headphones, earphones, and other types ofapplications, as will be readily understood by a person skilled in theart.

In at least one embodiment, the customizable ear insert may utilize aphotopolymer such that the ear insert can be photo-cured into acustomized fit within the user's outer ear or ear canal or both.

One embodiment of a customizable ear insert (10) in accordance with thepresent invention is illustrated in FIG. 1. In this embodiment, an outersleeve (1) surrounds the exterior of customizable ear insert (10). Asettable resin forms the body (2) of customizable ear insert (10). In atleast one embodiment, it is contemplated that the settable resin is aphotocurable polymer, however other arrangements are also contemplatedthat will be readily appreciated by the skilled person.

In at least one embodiment, a gas-containing chamber can be providedthat acts as a bladder (3) to expand and contract to improve the fitwithin the user's outer ear or ear canal or both. An internal cavity(5), can further be seen which can house optional equipment such as, forexample, at least one speaker (6), at least one sound bore (7), amicropump in fluid communication with the bladder (3), and at least onemicrophone (9), as required by the particular embodiment of the presentinvention. Further, it is contemplated that at least one embedded lightsource (4) can be stored in body (2) or cavity (5) or elsewhere (seeFIG. 2) depending on the needs and particular configuration of theinstant application.

Another embodiment of customizable ear insert (10) is illustrated inFIG. 2. In this embodiment, an outer sleeve (1) surrounds a settableresin that forms body (2) of the ear piece. Sleeve (1) and/or body (2)can have an integrated mechanical attachment means (14), which caninclude, for example, a clip, press fit connection, snap fit connection,among any other suitable arrangement, thereby allowing sleeve (1) andbody (2) to be mechanically and removably connected to a housing (11).

In this embodiment, housing (11) can optionally contain at least onespeaker (6), at least one light source (4), at least one microphone (9),a battery (12), and an integrated circuit (such as, but not limited to,a chip for wireless (i.e.: Bluetooth) communication) (13). At least onesound bore (7) can also be provided that fluidly communicates witheither the at least one speaker (6) or the at least one microphone (9)in order to conduct the sound through the body (2) and sleeve (1) andthereby directing the sound into the user's ear canal. In otherembodiments it is contemplated that the at least one sound bore (7) canalso be provided that fluidly communicates with either the at least onespeaker (6) or the at least one microphone (9) in order to conduct thesound through the body (2) and sleeve (1) and thereby directing thesound to the external environment

Finally, and as can be seen in FIG. 3, in some embodiments it iscontemplated that in some embodiments sleeve (1) has at least one groove(14) that can improve the fit and operation of customizable ear insert(10) within the user's outer ear, ear canal or both.

Body Component Overview

It is contemplated that customizable ear insert (10) may be constructedin a number of configurations as seen in FIGS. 1, 2 and 3. In at leastone embodiment, the construction of customizable ear insert (10)provides for body (2) to be fitted within the user's outer ear or earcanal or both. Body (2) may be constructed from any material such thatthe required rigidity characteristics are maintained. In at least oneembodiment and as discussed above, it is contemplated that body (2) maybe constructed from a photopolymer material. In these embodiments, it iscontemplated that the polymer may have varied malleabilitycharacteristics pre- and post-photo curing. Further, it is contemplatedthe photopolymer may be cured using any form of electromagnetic spectrumsuch as, but not limited to, visible light, ultraviolet light,fluorescent light, among other segments of spectrum readily understoodby the skilled person.

In at least one embodiment, body (2) is made from a photopolymer-typematerial such that the malleability is deformable and pliable such thatbody (2) may be able to change its form according to the pressuresexerted on its outer surface. It is contemplated that body (2) may beinserted into a user's outer ear or ear canal or both such that thedeformable properties of body (2) may contour to the internal shape ofthe user's outer ear or ear canal or both within a prescribeddeformability. The pliability of body (2) may be altered depending onapplication.

For example, smaller bodies made for children may require moredeformable specifications. In at least one embodiment, it iscontemplated that body (2) is constructed using modified urethane with aspecification property of 4,500 centipoise, however other arrangementswill be readily appreciated by the skilled person.

As will be readily appreciated by the skilled person, it is contemplatedthat body (2) may comprise one of, or a combination of: acrylates,methacrylates, urethane acrylates, and urethane methacrylates, amongother suitable materials that will be readily appreciated by the skilledperson. In at least one embodiment, it is contemplated that theviscosity can range from 30-5,000 centipoise.

In at least one embodiment, the shape of body (2) is constructed suchthat the shape of body (2) contours to a large percentage of human ears.Ergonomic and anatomic models and knowledge may be used in theconstruction of body (2) such that the shape of body (2) facilitatesintuitive placement into a user's outer ear or ear canal or both.

In at least one embodiment, sleeve (1) is affixed to body (2) such thatthe malleable body (2) is contained by sleeve (1). In at least oneembodiment, body (2) contains a flexible outer shell which functions tohold the body's internal composition intact during the pre-curingprocess. Sleeve (1) may be affixed to the outer shell either during thecuring process or post-curing process.

In at least one embodiment, body (2) is constructed of a gel-likematerial and is contained within sleeve (1). It is contemplated that theshape of sleeve (1) has elements that are designed to fit in acompatible part of the human anatomy (and specifically the user's outerear or ear canal or both), including the crus of the helix, cavumconcha, cymba concha, intertragic notch, and the outer ear or ear canalor both as will be readily appreciated by the skilled person. As will bereadily appreciated by the skilled person, sleeve (1) is designed tomake contact with key surfaces of the anti-helix, tragus, anti-tragus,and ear canal

In at least one embodiment it is contemplated that body (2) and sleeve(1) are designed with one or multiple grooves that allow the sleeve/bodyto expand, contract or deform as needed in order to conform a majorityof people's ears, as can be seen in FIG. 3.

In some embodiments, it is contemplated that both body (2) and sleeve(1) can be designed with a concave surface area on an outer surface toallow for the outflow of excess photopolymer during insertion of thedevice into the ear. In some embodiments, it is contemplated thatphotopolymer may be reintroduced into the ear by applying pressure onthe concave surface either manually or with an expandable bladder (3).

Light Source Component Overview

In order to cure photopolymer body (2), a light source (4) can beprovided such that body (2) is exposed to the respective type of lightsource (4) required for curing. As will be readily understood by theskilled person, the type of light source (4) is contingent upon thephotopolymer used. Light source (4) may emit, for example visible light,ultraviolet light, fluorescent light, infrared light, blue light, amongother segments of spectrum that will be readily understood by theskilled person. However and as will be understood by the skilled person,the application of the light source again varies on implementation.

In at least one embodiment, the typical wavelength utilized for lightsource (4) is 365 nm. In at least one embodiment, the typical wavelengthutilized for light source (4) is 470 nm. However, in other embodiments,the wavelength of light source (4) can be approximately between therange of 265 nm-500 nm.

In at least one embodiment, it is contemplated that the light source isembedded within customizable ear insert (10) such that both light source(4) and body (2) are coupled together. In some embodiments, light source(4) remains within body (2) post curing. It is contemplated that theembedded light source (4) may be of any portable light source including,but not limited to, LED(s), OLED(s), Quantum Dot, fluorescent bulbs,miniature incandescent bulbs, laser diodes, and other types of portablelight sources readily understood by the skilled person.

In at least one embodiment, light source (4) can be embedded withincustomizable ear insert (10) by depositing light source (4) directly oninside of body (2) and/or sleeve (1). In at least one embodiment,affixation of the embedded light source (4) includes depositing lightsource (4) on flexible or rigid substrate (not shown) which is theninstalled on inside of sleeve (1) and/or body (2). Depositing, foreither direct or indirect implementations, may be enabled by, forexample, chemical vapor deposition (CVD), physical vapor deposition(PVD), sputtering, spin coating, inkjet printing, and/or screenprinting. In at least one embodiment, light source (4) is a Quantum DotLED that includes the further step of dispersing within curable polymerresin and stimulating the resin by electric current and/or a lightsource disposed within customizable ear insert (10).

It is contemplated that light source (4) may be mounted in a number ofarrangements, depending on the embodiment, including: on a printedcircuit board (15) within housing (11), on a rigid or flexible substrate(not shown) that is affixed to an inner or outer surface of the housing(11), deposited directly on an inner and/or outer surface of housing(11), as required by the instant application of the present invention.It is contemplated that light source (4) may be of any portable lightsource including, but not limited to, LED(s), OLED(s), Quantum Dot,fluorescent bulbs, miniature incandescent bulbs, laser diodes, and anyother suitable type of portable light sources readily understood by theskilled person. Depositing, for either direct or indirectimplementations, may be enabled by chemical vapor deposition (CVD),physical vapor deposition (PVD), sputtering, spin coating, inkjetprinting, and/or screen printing, among any other techniques that willbe readily appreciated by the skilled person.

In at least one embodiment, light source (4) may be attachable to thecustomizable ear insert and also has the ability to be removed postcuring. Light source (4) can be constructed with dimensions such thatlight source (4) may appear to be embedded into body (2), however postcuring, light source (4) can be removed physically from body (2). Thetypes of attachable light sources may be of any portable light sourceincluding, but not limited to, LED(s), OLED(s), Quantum Dot, fluorescentbulbs, miniature incandescent bulbs, laser diodes, and other types ofportable light sources readily understood by the skilled person.

In at least one embodiment, light source (4) may be utilized externallysuch that light source (4) may provide curing effect to body (2) whilenot affixed to body (2) at any time during the deformable state of body(2), or during the forming state of body (2). Light source (4) may be ofany arrangement or dimensions as it will only be used as an externalcomponent relative to body (2). Suitable types of external light sourcescan include, but are not limited to, LED(s), OLED(s), Quantum Dot,fluorescent bulbs, miniature incandescent bulbs, halogen lamps, UVgenerators, infrared generators, spotlights, focal light sources, laserdiodes, and other types of portable light sources readily understood bythe skilled person.

In at least one embodiment, light source (4) may be utilized externallyand may be coupled to the customizable ear insert with optical fibers.In at least one embodiment, the optical fibers may transmit the lightfrom light source (4) throughout body (2). It is contemplated that theoptical fibers may be permanently or removably affixed to body (2). Thetypes of external light sources can include, but are not limited to,LED(s), OLED(s), Quantum Dot, fluorescent bulbs, miniature incandescentbulbs, halogen lamps, UV generators, infrared generators, spotlights,focal light sources, laser diodes, and other types of portable lightsources readily understood by the skilled person.

In at least one embodiment, light source (4) may be embedded incustomizable ear insert (10) and light source (4) may be coupled withoptical fibers that are embedded in the customizable ear insert. Theembedded light source may be of any portable light source including, butnot limited to, LED(s), OLED(s), Quantum Dot, fluorescent bulbs,miniature incandescent bulbs, laser diodes, and other types of portablelight sources readily understood by the skilled person. In at least oneembodiment, affixation of the embedded light source (4) includesdepositing light source (4) on flexible or rigid substrate (not shown)which can then be installed on the inside of sleeve (1), body (2) orhousing (11) as required by the needs of the instant application.

In at least one embodiment, specialized semiconductor materials areimplemented in connection with light source (2) including, but notlimited to, Indium Galium Nitride (InGaN), Gallium Nitride (GaN), andAluminum Gallium Nitride (AlGaN). These particular materials can providefor emission of ultraviolet light. In some embodiments, it iscontemplated that light source (4) may be powered by a number of methodsdepending on the application of light source (4). In embodiments wherelight source (4) is external, light source (4) may run on proprietarypower sources. In integrated embodiments, light source (4) may utilizepower from the user device to power the light source through thecommunication means (e.g., auxiliary cable, USB cable). In at least oneembodiment, the light sources employ voltage and/or current regulatingcircuits to optimize power consumption. In at least one embodiment,light source (4) can be integrated with embedded batteries (12) forself-sustaining power.

Curing Process

It will be readily understood that the curing process is dependent onthe implementation of the type of light source and photopolymerselected. In some embodiments, the curing process utilizeselectromagnetic radiation triggering polymerization of the selectedphotopolymer. In some embodiments, photopolymers consisting of a varietyof monomers and oligomers are cross-linked upon exposure to light,forming what is known as a network polymer; effectively constructing acured network of polymers.

As will be readily understood by the skilled person, the curing processis initiated by a number of mechanisms and responds to a number ofvarious inputs and other modules. Once initiated, the curing processcontinues for a calculated duration in order to transform body (2) froma first shape, which is deformable and pliable, to a second shape, whichis rigid and shape retentive.

In at least one embodiment, the curing process may be pre-configured tocure for a defined duration and has a single cycle for curing. This maybe pre-programmed into the embedded circuitry within light source (4).

In at least one embodiment, dependent on configuration, the curingprocess may last 10 seconds. In other embodiments, dependent onconfiguration, it is contemplated that the curing process may last 10minutes, among other arrangements that will be readily contemplated bythe skilled person.

In at least one embodiment, body (2) may be constructed from one, or acombination of the following polymers: acrylate, methacrylate, urethane,acrylated urethane, polyester, silicone. In at least one embodiment, itis contemplated that the corresponding LEDs for curing this photocurablepolymer emit light in the wavelength of 365 nm-500 nm.

In at least one embodiment, it is contemplated that the initiation ofthe curing process may be done remotely utilizing a network enableddevice. In these embodiments, the device may provide the particularinstructions by a communication means to the customizable ear insert,and in turn, the light source implements the instructions given from thedevice. Further, it is contemplated the device may implementinstructions from an Application “App” or a network-based instruction(e.g., through online website calibration, or cloud based service). Inthese embodiments, it is contemplated that utilizing the onlineconfiguration through the device allows for additional parameters to betaken into consideration.

Bladder Implementation

In at least one embodiment and as can be seen in FIG. 1, bladder (3)sits between the inner body and the polymer resin. Further, in someembodiments, it is contemplated that a micro-pump (8) can sit inside thebody (2) or housing (11) depending on the arrangement employed. It isalso contemplated that micro-pump (8) may be a single or dual directionpiezoelectric or electromagnetic diaphragm pump. In the case of anearplug application, micro-pump (8) may be located within the bladder(3).

Bladder (3) may be utilized to expand or contract body (2) based oninput that may be given to the bladder (3) utilizing a device withcommunication means to the ear piece. In this way, it is contemplatedthat an App can be implemented to control fit utilizing the bladdersystem.

Bladder (3) may be sealed and acted upon by a means for controlling thetemperature of the contained gas which can include but is not limited toatmospheric air. The temperature control apparatus can comprise, forexample, a resistive heating element or a peltier element, among otherarrangements that will be readily understood by the skilled person. Inthese embodiments, the thermal expansion of the gas within bladder (3)will serve to expand or contract body (2). In some embodiments, theheating and cooling elements can be contained in the bladder (3),contained in body (2), on the surface of sleeve (1), on the surface ofthe inner body, on the surface of the housing (11), or in the housing(11) with a means for being in fluid communication with the bladder (3)depending on the needs of the instant application.

It is contemplated that in some embodiments bladder (3) may sit betweenthe housing (11) and the sleeve (1) or body (2). Further, in someembodiments bladder (3) can consist of one or multiple pockets that areintegrated into the form of the sleeve (1).

Sleeve Implementation

In at least one embodiment, sleeve (1) is implemented for customized earinsert (10) such that sleeve (1) is applied on the outer surface of body(2), and/or body (2) and light source (4) configuration, depending onthe specific embodiment.

It is contemplated in at least one embodiment that sleeve (1) canphysically function as a cover material for the body. Further, it iscontemplated that sleeve (1) may be constructed of any materialdepending on its application. For headphone applications the materialused must allow for the output from the underlying speaker component (6)to function with a pre-defined acceptable audio quality.

In at least one embodiment the construction of the sleeve (1) may be anymaterial which allows for conformability to the underlying body (2) andprovides the requisite elasticity. The material for sleeve (1) mayinclude, but is not limited to, foam, silicone, cotton, wool, rubber,polymer, plastic, synthetic materials, natural materials, latex,thermoplastic vulcanizate, thermoplastic elastomer, thermoplasticpolyurethane, and over-molded combination of multiple materials.

In at least one embodiment, it is contemplated that sleeve (1) can beaffixed to body (2), while in other embodiments, it is contemplated thatsleeve (1) is removable from body (2).

In some embodiments it is contemplated that select inner or outersurfaces of sleeve (1) may be coated with a reflective material in orderto assist light propagation through the photopolymer.

In some embodiments, it is contemplated that a coating may be applied toselect areas of the inner and/or outer surface of sleeve (1) in order toblock or reduce unintended/undesired light exposure of the photopolymer.The coating may block all light transmission or select frequency bandsin the visible, infrared, and/or UV spectrums.

In some embodiments, it is contemplated that an additive may be blendedin to select areas of the sleeve material in order to block or reduceunintended/undesired light exposure of the photopolymer. The coating mayblock all light transmission or select frequency bands in the visible,infrared, and/or UV spectrums.

Mechanisms for Fit of Ear Insert

It is contemplated that the fit of the ear insert may be configuredutilizing a variety of mechanisms. In at least one embodiment,transducers (19) are implemented within body (2) such that variousmetrics can be measured as the ear insert is worn by a user. Thetransducers (19) are of sufficient dimension such that they are embeddedin body (2) or affixed to the sleeve (1). In at least one embodiment,the transducers (19) are powered by a communication means.

In at least one embodiment, it is contemplated that the transducers (19)are adapted to send data wirelessly to receivers. It is contemplatedthat the receivers may be any device configured to receive thetransmission from the transducers (19). For example, in at least oneembodiment, the device may be a network enabled device. In someembodiments, the device receiving the data, computes the ideal pressurebased on a variety of factors including, but not limited to, user'spersonal information input, the health and safety regulations forauditory devices, any other guidelines readily understood by the skilledworker. The computed adjustment is sent back to the transducers (19),either wirelessly or through communication means, to implement thecomputed adjustment for desired configuration.

In at least one embodiment, it is contemplated that the transducers (19)are pressure sensors. The pressure sensors may be of any type ofpressure sensor, including but not limited to strain gauges. Thepressure sensors measure the pressure of the ear pushing against thebody of the ear insert. In some embodiments, the data is recorded andstored within the sensor mechanism. The transfer of the data may occurwirelessly when a compatible device is within range, or alternativelycan wait until a physical connection is made using a conventionalcommunication means such as USB.

In at least one embodiment, an App is implemented on a device wherebythe configuration for pre-configured pressures can be applied. In someembodiments, a calibration option may exist on the App allowing userconfiguration of pre-configured pressures. Alternatively, a calibrationoption may exist on the App allowing for the user of the ear insert toadjust the pressure of the body prior to photopolymer body curing. In atleast one embodiment, the App is operable as the photopolymer body (2)is curing. The user may provide feedback to the App and customize thepressure of body (2) against their ear in real time. In someembodiments, the user may also compare his desired fit againstrecommended and/or pre-set configuration for pressure recommended byother users, manufacturers, medical practitioners, and/or industryexperts.

In at least one embodiment, the calibration receives feedback from oneor more feedback modules via a communication means. For example, thefeedback modules could be one or more microphones (9) which areconnected through a USB cable to the user device. Feedback modules couldbe one or more microphones embedded in specific locations in theearphones and communicate with user device via wireless integratedcircuit. The information sent from microphones (9) to the user device isthen compared to a set of pre-set values for calibration. These valuescould be part of a network-enabled database which the user device isconnected to. In such a way, the information from microphones (9) issent to the database for a comparison to determine what manipulation isrequired for the fit of the customized ear piece based on the feedbackfrom the one or more microphones (9). The user then follows instructionsprovided by the user device and the test then iterates until themicrophone feedback matches the calibration pre-sets in the database toa certain threshold.

Cavity Embodiment

In at least one embodiment, a cavity (5) is pre-constructed into body(2) of the customizable ear insert (10). Cavity (5) may serve any numberof purposes depending on instant application of customizable ear insert(10). In at least one embodiment, cavity (5) serves to allow for theinsertion of hearing system components. In at least one embodiment,cavity (5) serves to allow for the insertion of transducers. In at leastone embodiment, the shape and configuration of cavity (5) serves toallow for a desired audial response profile.

In at least one embodiment, cavity (5) is constructed with a mechanismallowing for attachment of one or more hearing system components, ortransducers. The attachments can be attached and removed andinterchanged at the will of the user.

In at least one embodiment, cavity (5) is constructed such that theimplementation of one or more hearing system components or transducersis affixed to the cavity (5) and integrated during fabrication, orthereafter, such that the components are not detachable.

Microphones Embodiment

In at least one embodiment, cavity (5) is configured to house one ormore microphones (9). As will be readily appreciated by the skilledperson, the microphones may serve any number of purposes depending onapplication of customizable ear insert (10).

In at least one embodiment, microphone (9) is utilized for calibrationof customizable ear insert (10) by detecting, for example, air flow,wind speed or ambient environmental sound. In other embodiments,microphone (9) may be configured such that one microphone is on theexterior of the body while one microphone is on the inner section ofbody (2) (e.g., the side of the body with a potential speakerconfiguration). Each microphone may send audial information to thedevice by a communication means. The device may determine variousmetrics such as “leakage” of air between customizable ear insert (10)and the user's ear. In this case, the microphone may be used tocalibrate the fit of customizable ear insert (10) within the user's ear.The interface between the microphone and the information provided may beconducted through an App on the user's device.

In at least one embodiment, it is contemplated that one microphonemeasures sound pressure level on the exterior of the ear insert and asecond microphone measures sound pressure level at the proximal tip ofthe ear insert inside the ear. In these embodiments, the noise levelreduction, which can be measured in decibels, will be used to determinewhen an adequate seal has been achieved.

In at least one embodiment, the calibration utilizing the microphonesmay be utilized to calibrate the fit of customizable ear piece (10)prior to the curing of customizable ear insert (10). The microphones maybe used to measure bypass sound pressure levels at predeterminedlocations on body (2). In this way, the App utilizes the informationsent by the microphones in order to map the correct pressure to ensurethe optimal spatial fit of customizable ear insert (10).

In at least one embodiment, the one or more microphone (9) may beutilized to provide noise cancelling of ambient sound utilizingtechniques readily understood by a person skilled in the art.

Speakers Embodiment

In at least one embodiment, cavity (5) is configured to house one ormore speakers (6) to provide audial output. In at least one embodiment,speakers (6) can be attached to the device (affixed or detachable) suchthat speakers (6) are fully integrated within the mold of body (2) toprovide audial output to the user.

In at least one embodiment, speakers (6) are utilized for calibration ofcustomizable ear insert (10) by providing audial tests to the user basedon environmental conditions. The interface between speakers (6) and theinformation provided may be conducted through an App on the user'sdevice. The App may contain a simulation of ideal audial response andrequisition the user to complete a survey regarding the response andclarity of audio based on user action.

In at least one embodiment, speakers (6) are utilized for calibration byproducing audial tones at specific frequencies and sound pressurelevels. In embodiments where microphones are provided on the exterior ofbody (2) may be used to measure the presence of these tones. The noiselevel reduction, measured in decibels, will therefore be used todetermine when an adequate seal has been achieved.

It is obvious that the foregoing embodiments of the invention areexamples and can be varied in many ways. Such present or futurevariations are not to be regarded as a departure from the spirit andscope of the invention, and all such modifications as would be obviousto one skilled in the art are intended to be included within the scopeof the following claims.

What is claimed is:
 1. A customizable ear insert for insertion into anouter ear and an ear canal of a user, comprising: a body formed of aphotocurable polymer which has a first shape that is deformable andpliable; a light source configured to emit radiation to cure thephotocurable polymer, wherein the light source is positioned within ahousing; a sleeve that surrounds at least a portion of the body, whereinthe sleeve comprises an elastic material; and an integrated circuitpositioned within the housing, the integrated circuit configured forwireless communication and configured to enable the emission of theradiation from the light source, and when a portion of the sleeve andthe body are positioned within the ear canal of the user and exposed tothe radiation emitted from the light source, the sleeve and the bodyform a shape-retentive second shape adapted to conform to a portion ofouter ear of the user.
 2. The customizable ear insert of claim 1,further comprising an attachment means, wherein the attachment meansallows the sleeve and body to be mechanically and removably connected tothe housing.
 3. The customizable ear insert of claim 2, wherein theattachment means comprises a snap fit.
 4. The customizable ear insert ofclaim 1, wherein the housing further comprises embedded batteries thatare coupled to the light source.
 5. The customizable ear insert of claim1, wherein the sleeve is affixed to the body.
 6. The customizable earinsert of claim 1, wherein the elastic material is selected from thegroup consisting of thermoplastic polyurethane and silicone.
 7. Thecustomizable ear insert of claim 1, further comprising one or moretransducers that are embedded within the body, and configured to measurepressure applied to the body.
 8. The customizable ear insert of claim 7,wherein the one or more transducers comprise strain gauges.
 9. Thecustomizable ear insert of claim 1, further comprising a cavity locatedwithin the housing.
 10. The customizable ear insert of claim 9, whereinthe cavity is adapted to receive at least one speaker.
 11. Thecustomizable ear insert of claim 9, wherein the cavity is adapted toreceive at least one microphone, wherein the at least one microphone isa first microphone located in the housing.
 12. The customizable earinsert of claim 11, wherein the at least one microphone includes thefirst microphone and a second microphone located in the body.
 13. Thecustomizable ear insert of claim 12, wherein the first microphone andthe second microphone are configured to detect at least one of: audialleakage from the ear canal to an external environment and audial leakagefrom the external environment to the ear canal.
 14. The customizable earinsert of claim 11, wherein the first microphone is adapted to fluidlycommunicate with the outer ear and an external environment by way of asound bore.
 15. A customizable ear insert for insertion into an outerear and an ear canal of a user, comprising: a body formed of aphotocurable polymer which has a first shape that is deformable andpliable; a light source configured to emit radiation to cure thephotocurable polymer, wherein the light source is positioned within ahousing; a sleeve that surrounds at least a portion of the body; and anintegrated circuit positioned within the housing, the integrated circuitconfigured for wireless communication and configured to enable theemission of the radiation from the light source; wherein whenpositioning a portion of the sleeve and the body within the outer ear ofthe user and exposing the portion of the sleeve and the body to theradiation emitted from the light source, the sleeve and the body form ashape-retentive second shape adapted to conform to a portion of theouter ear of the user.
 16. The customizable ear insert of claim 15,further comprising an attachment means, wherein the attachment meansallows the sleeve and body to be mechanically and removably connected tothe housing.
 17. The customizable ear insert of claim 15, wherein thehousing comprises embedded batteries that are coupled to the lightsource.
 18. A customizable ear insert for insertion into an outer earand an ear canal of a user, comprising: a body formed of a photocurablepolymer which has a first shape that is deformable and pliable; a lightsource configured to emit radiation that will cure the photocurablepolymer, wherein the light source is positioned within a housing; asleeve that surrounds at least a portion of the body, wherein the sleevecomprises an elastic material; and an attachment means; wherein theattachment means allows the sleeve and body to be mechanically andremovably connected to the housing, and when a portion of the sleeve andthe body are positioned within the ear canal of the user and exposed tothe radiation emitted from the light source, the sleeve and the bodyform a shape-retentive second adapted to conform to a portion of the earcanal of the user.
 19. The customizable ear insert of claim 18, furthercomprising a communication means that is configured to receive powerfrom an external device to enable the emission of the radiation from thelight source.
 20. The customizable ear insert of claim 18, wherein thehousing further comprises embedded batteries that are configured toprovide power to the light source.